In a randomized trial, 294 patients with advanced heart failure were assigned to receive either a new centrifugal-flow pump or an axial-flow pump. At 6 months, the centrifugal-flow pump was ...associated with better outcomes.
A scarcity of effective therapeutic options for advanced heart failure has led to the development of durable mechanical circulatory support devices. Left ventricular assist devices, more accurately known as left ventricular assist systems, increase the rate of survival and improve quality of life among patients with advanced heart failure. However, these clinical benefits are balanced by an increased risk of infection, bleeding, neurologic events, and pump malfunction that is due principally to pump thrombosis.
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As adoption of circulatory pumps has expanded, concerns about pump thrombosis have heightened. In 2013, two reports suggested that there has been an increase in . . .
Objectives The objective of the study was to determine the prevalence of bleeding during continuous-flow left ventricular assist device support and to identify potential mechanisms for those bleeding ...events. Background Bleeding is frequently reported with continuous-flow left ventricular assist devices and may result from anticoagulation coupled with bleeding diathesis such as acquired von Willebrand syndrome. Accordingly, the prevalence of coagulation abnormalities including laboratory assessment for von Willebrand syndrome, bleeding events during device support, and at heart transplantation were evaluated. Methods A retrospective study in all HeartMate II (HM II) (Thoratec Corp., Pleasanton, California) patients who underwent implantation between April 1, 2004, and August 1, 2009, was performed. Bleeding was defined as the need for transfusion >7 days after device insertion of 1 U of packed red blood cells. Transfusion at heart transplantation was compared with that in HeartMate XVE patients. Results Seventy-nine HM II devices were implanted. Anticoagulation included warfarin in 68.3%, aspirin in 55.7%, and dipyridamole in 58.2% of the patients. Of the patients, 44.3% had bleeding episodes at 112 ± 183 days after left ventricular assist device implantation, with 50% experiencing an event within 2 months. Gastrointestinal bleeding was the most frequent event. At the index event, the international normalized ratio averaged 1.67 ± 0.53, and the platelet count was 237 ± 119 × 109 /l. Comparison of the transfusion requirements at heart transplantation of 35 HM II patients with 62 HeartMate XVE patients demonstrated twice the transfusion requirements in HM II patients (packed red blood cells, 6.3 ± 0.8 U vs. 3.8 ± 0.5 U; platelets, 12.5 ± 5.4 U vs. 8.6 ± 6.4 U; fresh frozen plasma, 9.6 ± 4.9 U vs. 4.9 ± 3.6 U; and cryoprecipitate, 4.3 ± 3.6 U vs. 2.2 ± 3.5 U; p < 0.05 for all). High molecular weight von Willebrand factor multimers were measured in 31 HM II patients and were reduced in all patients; 18 of these 31 (58%) patients had bleeding. Conclusions Patients with the HM II had a high incidence of bleeding events during device support and at heart transplantation. All HM II patients had reduced high molecular weight von Willebrand factor multimers. The role of these abnormalities in the high incidence of bleeding deserves further investigation. Furthermore, alterations in anticoagulation should be considered during device support and before surgery in patients supported with the HM II.
Summary Background The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts. The system preserves the donor heart in a warm beating state during transport from ...the donor hospital to the recipient hospital. We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation. Methods We did this prospective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe. Eligible heart-transplant candidates (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the Organ Care System or standard cold storage. Participants, investigators, and medical staff were not masked to group assignment. The primary endpoint was 30 day patient and graft survival, with a 10% non-inferiority margin. We did analyses in the intention-to-treat, as-treated, and per-protocol populations. This trial is registered with ClinicalTrials.gov , number NCT00855712. Findings Between June 29, 2010, and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care System group (n=67) or the standard cold storage group (n=63). 30 day patient and graft survival rates were 94% (n=63) in the Organ Care System group and 97% (n=61) in the standard cold storage group (difference 2·8%, one-sided 95% upper confidence bound 8·8; p=0·45). Eight (13%) patients in the Organ Care System group and nine (14%) patients in the standard cold storage group had cardiac-related serious adverse events. Interpretation Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes. The metabolic assessment capability of the Organ Care System needs further study. Funding TransMedics.
Cardiogenic shock (CS) remains the most common cause of mortality in patients with acute myocardial infarction. The SHOCK trial (Should We Emergently Revascularize Occluded Coronaries for Cardiogenic ...Shock) demonstrated a survival benefit with early revascularization in patients with CS complicating acute myocardial infarction (AMICS) 20 years ago. After an initial improvement in mortality related to revascularization, mortality rates have plateaued. A recent Society of Coronary Angiography and Interventions classification scheme was developed to address the wide range of CS presentations. In addition, a recent scientific statement from the American Heart Association recommended the development of CS centers using standardized protocols for diagnosis and management of CS, including mechanical circulatory support devices (MCS). A number of CS programs have implemented various protocols for treating patients with AMICS, including the use of MCS, and have published promising results using such protocols. Despite this, practice patterns in the cardiac catheterization laboratory vary across health systems, and there are inconsistencies in the use or timing of MCS for AMICS. Furthermore, mortality benefit from MCS devices in AMICS has yet to be established in randomized clinical trials. In this article, we outline the best practices for the contemporary interventional management of AMICS, including coronary revascularization, the use of MCS, and special considerations such as the treatment of patients with AMICS with cardiac arrest.
Primary graft dysfunction (PGD) is one of the most common causes of early death after orthotopic heart transplantation. Mechanical circulatory support devices are required for severe forms of PGD. ...Venoarterial extracorporeal membrane oxygenation (VA-ECMO) and temporary ventricular assist device (VAD) support have both been reported to be useful for severe PGD.
Between January 2007 and December 2015, 597 patients received a heart transplant at our center. Of those, severe PGD developed in 44 patients (7.4%), and they received a continuous-flow external VAD (n = 17) or VA-ECMO (n = 27) support within 24 hours after transplant. We compared early and late outcomes between groups.
Baseline characteristics were similar between groups. Implantation of the temporary VAD required longer cardiopulmonary bypass time compared with VA-ECMO (323 ± 86 minutes vs 216 ± 65 minutes, p < 0.0001). Patients who received a VAD were more likely to have longer support time (14 ± 17 days vs 5.2 ± 3.9 days, p = 0.011), a higher incidence of major bleeding requiring chest reexploration (77% vs 30%, p = 0.0047), and a higher incidence of renal failure requiring renal replacement therapy (53% vs 11%, p = 0.0045) after surgery. Overall hospital mortality was 27%. In-hospital mortality for VAD and VA-ECMO patients were 41% and 19%, respectively (p = 0.16). Ten patients (59%) were weaned from VAD support, and 24 (89%) were weaned from VA-ECMO support after adequate graft function recovery (p = 0.03). The 3-year post-transplant survival was 41% in the VAD group and 66% in the VA-ECMO group (p = 0.13).
For severe PGD, support with VA-ECMO appears to result in better clinical outcomes compared with VAD.
Aim
The MOMENTUM 3 pivotal trial established superiority of the HeartMate 3 (HM3) left ventricular assist device (LVAD), a fully magnetically levitated centrifugal‐flow pump, over the HeartMate II ...axial‐flow pump. We now evaluate HM3 LVAD outcomes in a single‐arm prospective continuous access protocol (CAP) post‐pivotal trial study.
Methods and results
We enrolled 2200 HM3 implanted patients (515 pivotal trial and 1685 CAP patients) and compared outcomes including survival free of disabling stroke or reoperation to replace or remove a malfunctioning device (primary composite endpoint), overall survival and major adverse events at 2 years. The 2‐year primary endpoint 76.7% vs. 74.8%; adjusted hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.71–1.08, P = 0.21 and overall survival (81.2% vs. 79.0%) were similar among CAP and pivotal cohorts despite sicker patients (more intra‐aortic balloon pump use and INTERMACS profile 1) in CAP who were more often intended for destination therapy. Survival was similar between the CAP and pivotal trial in transplant ineligible patients (79.1% vs. 76.7%; adjusted HR 0.89, 95% CI 0.68–1.16, P = 0.38). In a pooled analysis, the 2‐year primary endpoint was similar between INTERMACS profiles 1–2 (‘unstable’ advanced heart failure), profile 3 (‘stable’ on inotropic therapy), and profiles 4–7 (‘stable’ ambulatory advanced heart failure) (75.7% vs. 77.6% vs. 72.9%, respectively). The net burden of adverse events was lower in CAP (adjusted rate ratio 0.93, 95% CI 0.88–0.98, P = 0.006), with consequent decrease in hospitalization.
Conclusions
The primary results of accumulating HM3 LVAD experience suggest a lower adverse event burden and similar survival compared to the pivotal MOMENTUM 3 trial.
Accumulating post‐pivotal trial experience with the HeartMate 3 (HM3) left ventricular assist device (LVAD) suggests a lower adverse event burden, reduced hospitalizations and similar survival free of disabling stroke or reoperation to replace or remove a malfunctioning pump as compared to the pivotal MOMENTUM 3 trial outcomes at 2 years. These beneficial outcomes were noted across the continuum of clinical severity in advanced heart failure and especially among transplant ineligible patients in whom outcomes may now compare favourably with those in transplant eligible patients at 2 years.
Objectives Cardiogenic shock after cardiac surgery is accompanied by a high mortality rate. Early institution of hemodynamic support with a versatile, easy to insert left ventricular assist device ...might help bridge patients to recovery or to the next therapy, and improve the outcomes. Methods Patients developing cardiogenic shock or low cardiac output syndrome after being weaned off cardiopulmonary bypass were enrolled in a prospective single-arm feasibility study (RECOVER I). The primary safety endpoint was the frequency of major adverse events (death, stroke) at 30 days or discharge, whichever was longer. The primary efficacy endpoint was survival of the patient to implementation of the next therapy, which included recovery at 30 days after device removal and bridge-to-other-therapy. Results Sixteen patients provided informed consent and were enrolled in the study. Hemodynamics improved immediately after the initiation of mechanical support: cardiac index, 1.65 versus 2.7 L/min/m2 ( P = .0001); mean arterial pressure, 71.4 versus 83.1 mm Hg ( P = .01); and pulmonary artery diastolic pressure, 28.0 versus 19.8 mm Hg ( P < .0001). The pump provided an average of 4.0 ± 0.6 L/min of flow for an average duration of 3.7 ± 2.9 days (range, 1.7–12.6). The primary safety endpoint occurred in 2 patients (13%; 1 stroke and 1 death). For the primary efficacy endpoint, recovery of the native heart function was obtained in 93% of the patients discharged, with bridge-to-other-therapy in 7%. Survival to 30 days, 3 months, and 1 year was 94%, 81%, and 75%, respectively. Conclusions The use of the Impella 5.0/left direct device is safe and feasible in patients presenting with postcardiotomy cardiogenic shock. The device was rapidly inserted, enabled early support, and yielded favorable outcomes.
Right heart failure (RHF) is an unresolved issue during continuous-flow left ventricular assist device (LVAD) support. Little is known about the incidence and clinical significance of late RHF during ...LVAD support.
Between May 2004 and December 2013, 336 patients underwent continuous-flow LVAD implantation. Of these, 293 patients (87%) discharged with isolated LVAD support were included in this study. Late RHF was defined as HF requiring re-admission and medical or surgical intervention after initial surgery.
Late RHF occurred in 33 patients (11%) at a median of 99 days after discharge (range 19 to 1,357 days). Freedom from late RHF rates were 87%, 84% and 79% at 1, 2 and 3 years, respectively. RHF recurred in 15 patients. Three patients required right ventricular assist device insertion. Univariable Cox proportional hazards regression model showed diabetes mellitus (HR 2.05, 95% CI 1.03 to 4.06, p = 0.04), body mass index >29 (HR 2.47, 95% CI 1.24 to 4.94, p = 0.01) and blood urea nitrogen level >41 mg/dl (HR 2.19; 95% CI 1.10 to 4.36; p = 0.025) as significant predictors for late RHF. Estimated on-device survival rates at 2 years were 73% in the RHF group and 82% in the non-RHF group (p = 0.20). However, overall survival at 2 years was significantly worse in patients who developed late RHF (60% vs 85%, p = 0.016). This reduction was mostly attributed to worse overall outcomes in the bridge-to-transplant (BTT) population.
Late RHF is common after continuous-flow LVAD implantation, but does not affect survival during LVAD support. However, it is associated with worse overall outcomes in the BTT population.
The use of a right ventricular assist device (RVAD) becomes necessary for severe right ventricular (RV) failure after left ventricular assist device (LVAD) insertion. Although temporary support could ...lead to successful RVAD weaning in certain patients, the data remain scarce.
We retrospectively reviewed 398 patients who underwent implantable LVAD insertion between January 2000 and December 2012. Of these patients, 44 (11%) required unplanned RVAD support due to severe RV failure after LVAD insertion. For comparison, 37 patients who underwent planned biventricular assist device (BiVAD) insertion were identified during the same study period. We analyzed the early and late outcomes in these patients.
The mean duration of RVAD support was 21 ± 23 days. Of the 44 patients, 21 (49%) were weaned from the RVAD (weaning group), whereas 23 (51%) required continued biventricular support (failure group). The failure group had ongoing end-organ dysfunction after RVAD insertion. Hospital mortality was significantly lower in the weaning group (24%) and in the planned BiVAD group (30%) as compared to the failure group (74%, p = 0.0009). The 6-month actuarial survival rate was 75% in the weaning group, 62% in the planned BiVAD group and 13% in the failure group (p < 0.0001). Successful bridge to transplant was achieved in 14 patients (67%) in the weaning group as compared with 8 patients (35%) in the failure group (p = 0.03). On multivariate logistic regression analyses, pre-operative white blood cell (odds ratio OR 1.3, 95% confidence interval CI 1.04 to 1.50, p = 0.016) and creatinine (OR 0.26, 95% CI 0.079 to 0.88, p = 0.03) levels were significant predictors for RVAD removal.
Among patients who developed acute RV failure after LVAD insertion, only half could be weaned from the temporary RVAD support. An alternative strategy is necessary in patients who require continuous RVAD support.
Mortality for refractory cardiogenic shock (RCS) remains high. However, with improving mechanical circulatory support device (MCSD) technology, the treatment options for RCS patients are expanding. ...We report on a recent 5-year single-center experience with MCSD for treatment of RCS.
This study was a retrospective review of adult patients who required an MCSD due to RCS in the past 5 years. We excluded those patients with post-cardiotomy shock and post-transplant cardiac graft dysfunction. In the setting of RCS, a short-term ventricular assist device (VAD) was inserted as a bridge-to-decision device. Veno-arterial extracorporeal membrane oxygenation (VA ECMO) was chosen in cases of unknown neurologic status, complete hemodynamic collapse or severe coagulopathy.
From January 2007 through January 2012, 90 patients received an MCSD for RCS, 21 (23%) of whom had active cardiopulmonary resuscitation (CPR). The etiology of RCS included acute myocardial infarction in 49% and acute decompensated heart failure in 27%. Mean age was 53±14 years, 71% were male, and 60% had an intra-aortic balloon pump. The initial approach utilized was short-term VAD in 49% and VA ECMO in 51%. Median length of support was 8 days (IQR 4 to 18 days). Exchange to implantable VAD was performed in 26% of patients. Other destinations included myocardial recovery in 18% and heart transplantation in 11%. Survival to hospital discharge was 49%. Multivariate analysis showed ongoing CPR to be an independent risk factor for mortality (OR = 5.79, 95% CI 1.285 to 26.08, p = 0.022).
In the current era, roughly half of the patients who need an MCSD for RCS survive, and roughly half of these survivors require an implantable VAD. Ongoing CPR is predictive of in-hospital mortality.
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